---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-254597"
form_type: "8-K"
ticker: "DYN"
cik: "0001818794"
company_name: "Dyne Therapeutics, Inc."
filed_at: "2026-06-03T11:35:14+00:00"
generated_at: "2026-06-03T11:40:07.593316+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Dyne Therapeutics completes enrollment of ACHIEVE registrational cohort with 71 DM1 patients

## Summary
- Registrational expansion cohort (REC) enrolled 71 participants; topline data expected Q1 2027.
- Potential BLA submission for U.S. Accelerated Approval in Q3 2027 using REC and MAD/LTE data.
- Potential U.S. launch of z-basivarsen in H1 2028 if FDA grants Priority Review.
- Also pursuing approval pathways outside U.S. for DM1 therapy.
- ACHIEVE primary endpoint: change in middle finger myotonia via vHOT at 6 months vs placebo.

## SEC filing metadata
- accession: 0001193125-26-254597
- form_type: 8-K
- ticker: DYN
- cik: 0001818794
- company_name: Dyne Therapeutics, Inc.
- filed_at: 2026-06-03T11:35:14+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1818794/000119312526254597/0001193125-26-254597-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1818794/000119312526254597/dyn-20260603.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-254597
- JSON: https://secwatch.observer/filing/0001193125-26-254597.json
- Plain text: https://secwatch.observer/filing/0001193125-26-254597.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.